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Trial registered on ANZCTR


Registration number
ACTRN12624000622505
Ethics application status
Approved
Date submitted
26/04/2024
Date registered
14/05/2024
Date last updated
14/07/2024
Date data sharing statement initially provided
14/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The influence of a knee osteoarthritis diagnosis on people’s beliefs about the condition
Scientific title
Effects of a radiographic diagnosis and explanation of knee osteoarthritis on consumer beliefs about knee pain management: an online randomised controlled trial in adults aged 45 and over who have and have not experienced activity-related knee joint pain
Secondary ID [1] 311543 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 332897 0
Condition category
Condition code
Musculoskeletal 329615 329615 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The entire trial will be administered in one single online survey.

Eligible participants will be asked to imagine a hypothetical scenario where they have made an appointment with a General Practitioner (GP) to find out what is wrong with their painful knee. Participants will then be automatically randomised into one of three groups, all of which will be asked to watch a pre-recorded video on their screen where they receive a hypothetical knee osteoarthritis (OA) diagnosis from their GP.

The three groups will be:

i) Clinical diagnosis and explanation without being sent for x-ray: the video will show the GP providing a clinical diagnosis of knee OA based on their age and symptoms, including an explanation of why x-rays are not necessary for OA diagnosis. The GP will then explain what OA is. This will include the how it is diagnosed, basic pathogenesis, natural history and treatment options.

ii) Diagnosis and explanation based on x-ray findings (but without showing the x-ray images): the video will show the GP ordering an x-ray for the participant, summarising the x-ray report (but not showing the participant the x-ray images), and providing a diagnosis of knee OA. The GP will then explain what OA is. This will include the how it is diagnosed, basic pathogenesis, natural history and treatment options.

iii) Diagnosis and explanation based on x-ray (and showing the x-ray images): the video will show the GP ordering an x-ray for the participant, then summarising the x-ray report and Showing them the x-ray images, and providing a diagnosis of knee OA. The GP will then explain what OA is. This will include the how it is diagnosed, basic pathogenesis, natural history and treatment options.

The video for all groups will be scripted in a way that intends to reflect what typical language and communication style may look like in a real-world general practice setting. The video in each group is anticipated to last for 2-3 minutes.

With regards to fidelity, we will collect data on whether watched allocated video or not
time spent watching video.
Intervention code [1] 327999 0
Diagnosis / Prognosis
Comparator / control treatment
This is a three arm study, with the three groups described above. The reference comparator will be group 3, which will receive a diagnosis based on xray and will be shown the images.
Control group
Active

Outcomes
Primary outcome [1] 337404 0
Belief about joint replacement surgery
Timepoint [1] 337404 0
Single survey study - will be assessed immediately after watching the hypothetical knee consultation video
Primary outcome [2] 338165 0
Belief about exercise and physical activity.

Note: this is being is being asked as a single question. It is not a composite measure.
Timepoint [2] 338165 0
Single survey study - will be assessed immediately after watching the hypothetical knee consultation video
Secondary outcome [1] 433084 0
Belief about safety of exercise
Timepoint [1] 433084 0
Single survey study - will be assessed immediately after watching the hypothetical knee consultation video
Secondary outcome [2] 433085 0
Belief about medication
Timepoint [2] 433085 0
Single survey study - will be assessed immediately after watching the hypothetical knee consultation video
Secondary outcome [3] 433086 0
Level of concern
Timepoint [3] 433086 0
Single survey study - will be assessed immediately after watching the hypothetical knee consultation video
Secondary outcome [4] 433087 0
Fear of movement
Timepoint [4] 433087 0
Single survey study - will be assessed immediately after watching the hypothetical knee consultation video
Secondary outcome [5] 433088 0
Belief about orthopaedic surgeon
Timepoint [5] 433088 0
Single survey study - will be assessed immediately after watching the hypothetical knee consultation video
Secondary outcome [6] 433089 0
Belief about rheumatologist
Timepoint [6] 433089 0
Single survey study - will be assessed immediately after watching the hypothetical knee consultation video
Secondary outcome [7] 433090 0
Belief about physiotherapist
Timepoint [7] 433090 0
Single survey study - will be assessed immediately after watching the hypothetical knee consultation video
Secondary outcome [8] 433091 0
Overall satisfaction
Timepoint [8] 433091 0
Single survey study - will be assessed immediately after watching the hypothetical knee consultation video
Secondary outcome [9] 433092 0
Satisfaction with information
Timepoint [9] 433092 0
Single survey study - will be assessed immediately after watching the hypothetical knee consultation video
Secondary outcome [10] 433093 0
Confidence
Timepoint [10] 433093 0
Single survey study - will be assessed immediately after watching the hypothetical knee consultation video

Eligibility
Key inclusion criteria
Participants will be eligible for the study if they meet the following inclusion criteria:
i) Adults aged 45 years or over;
ii) Currently living in Australia;
iii) Either have, and have not, experienced activity-related knee joint pain in the last 3 months; and
iv) Have never consulted a healthcare professional for chronic knee pain.

Note: We will recruit a sample of 50% who have knee pain, and 50% who do not have knee pain.
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Inability to understand or read English

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
After completing baseline measures, participants will be automatically randomised to one of the three groups by the Qualtrics software (using the “randomiser” feature set to evenly present elements at a 1:1:1 ratio).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This will be done by the Qualtrics software, using the “randomiser” feature set to evenly present elements at a 1:1:1 ratio. The order of group allocation is performed automatically by Qualtrics and is not known to researchers.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
We will use complete case analyses. A Statistical Analysis Plan will be written prior to data analysis commencing and published on our Centre’s website. Briefly, for primary outcomes and other secondary outcomes, mean differences in post-intervention scores between groups will be estimated via linear mixed-effects models.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/05/2024
Actual
16/05/2024
Date of last participant enrolment
Anticipated
31/05/2024
Actual
25/05/2024
Date of last data collection
Anticipated
31/05/2024
Actual
25/05/2024
Sample size
Target
609
Accrual to date
Final
618
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 315840 0
Government body
Name [1] 315840 0
National Health and Medical Research Council (NHMRC) Grant (#2025733)
Country [1] 315840 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 317967 0
None
Name [1] 317967 0
Address [1] 317967 0
Country [1] 317967 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314695 0
University of Melbourne Central Human Research Ethics Committee
Ethics committee address [1] 314695 0
https://research.unimelb.edu.au/work-with-us/ethics-and-integrity/our-ethics-committees
Ethics committee country [1] 314695 0
Australia
Date submitted for ethics approval [1] 314695 0
08/04/2024
Approval date [1] 314695 0
09/05/2024
Ethics approval number [1] 314695 0
2024-29162-53195-3

Summary
Brief summary
Unfortunately, many people will experience knee osteoarthritis at some point in their life. This can be diagnosed by a General Practitioner (GP) or other health professional, and there are different ways this may be done. People often have beliefs about treatments for, and the prognosis of, their knee osteoarthritis. Currently, we do not know whether the way someone is diagnosed with knee osteoarthritis makes any difference to their beliefs about treatment or prognosis. This study is interested in learning more about whether the way people are diagnosed with knee osteoarthrtitis changes their beliefs about the condition. We hypothesise that a diagnosis and explanation without x-ray will reduce beliefs that surgery is necessary and increase beliefs that exercise is helpful, compared to a diagnosis and explanation based on x-ray.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132422 0
Dr Belinda Lawford
Address 132422 0
Centre for Health, Exercise and Sports Medicine Department of Physiotherapy School of Health Sciences, Alan Gilbert Building 161 Barry Street Carlton Victoria 3053
Country 132422 0
Australia
Phone 132422 0
+61 03 8344 2045
Fax 132422 0
Email 132422 0
[email protected]
Contact person for public queries
Name 132423 0
Belinda Lawford
Address 132423 0
Centre for Health, Exercise and Sports Medicine Department of Physiotherapy School of Health Sciences University of Melbourne Alan Gilbert Building 161 Barry Street Carlton Victoria 3053
Country 132423 0
Australia
Phone 132423 0
+61 03 83442045
Fax 132423 0
Email 132423 0
[email protected]
Contact person for scientific queries
Name 132424 0
Belinda Lawford
Address 132424 0
Centre for Health, Exercise and Sports Medicine Department of Physiotherapy School of Health Sciences University of Melbourne Alan Gilbert Building 161 Barry Street Carlton Victoria 3053
Country 132424 0
Australia
Phone 132424 0
+61 03 83442045
Fax 132424 0
Email 132424 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data relating to primary and secondary outcomes.
When will data be available (start and end dates)?
Immediately following publication, for a period of 15 years.
Available to whom?
Data will be made available as required for specific, approved analyses by researchers. Data will be provided from locked, cleaned, and de- identified study database. Requests will be reviewed by the Principal Investigator prior to approval.
Available for what types of analyses?
The investigators endorse the concept of data sharing to advance medical science. All requests for data sharing will be reviewed by the Principal Investigator to ensure no conflict with any planned sub analyses and to ensure that the data are shared in an ethical and protected manner. Analyses aimed to improve treatment of knee osteoarthritis for non-commercial purposes are eligible.
How or where can data be obtained?
By emailing the Principal Investigator at [email protected]. Data will be made available after review and approval by the Principal Investigator. Before any analysis, a signed Confidentiality Agreement and/or Data Sharing Agreement is required.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.